Build records still on travellers
E-signed steps and scanned lots replace the batch folder, as the device is built.
The DHR, as a by-product. Medical device manufacturing software.
The device history record is a batch folder of travellers, labels and sign-offs, and one missing signature sends the batch back. Bulk captures every lot, check and e-signature as the device is built, so the eDHR is ready at release.
- Electronic device history record
- Lot, serial & UDI traceability
- E-signed build steps
- NCR & CAPA on the floor
This is your floor. These are the modules on it.
Where Bulk fits best.
Lots you must trace both ways
Which lot went into which device, answered as a query, not an afternoon.
An eQMS that stops at the floor
Keep your eQMS, PLM and accounts; Bulk runs goods-in to finished device.
The DHR rebuilt before audits
Evidence captured as the work happens, so release is a review, not a rebuild.
From component receipt to released eDHR, one thread.
Receive & verify the lot
Goods-in books each component lot, its certificate and inspection result; unverified stock holds at the bay.
See data threadComponent lot verifiedGoods-in · Batch 4417 · today 07:48
Lot SL-2290 · CoC attached · incoming inspection passed · 500 cannulae
Released to build
Build it in the cleanroom
Each step e-signed, each lot scanned, each check recorded. The build record writes itself.
See productionStep 4: Blade assemblyProduction · Batch 4417 · Cleanroom 2
A. Mensah · lot SL-2290 scanned · e-signed 09:21
Step 4 of 9 signed
Catch and hold the nonconformance
An out-of-spec reading raises the NCR, quarantines the units and starts the disposition trail.
See qualityNCR-0331 raisedQuality · Batch 4417 · raised 11:06
Seal peel strength below limit on unit 212 of 500
Units 201–250 quarantined
Release the device history record
The eDHR assembles itself from lots, checks and signatures already captured: review, not collation.
See documentsDevice history recordDocuments · Batch 4417 · ready for release
6 component lots · 9 e-signed steps · 3 in-process checks · UDI applied
Complete, no gaps
Today's reality: built on paper.
The DHR is a stack of paper
A missing signature in the batch folder sends the whole lot back.
Genealogy lives in three places
A spreadsheet, a label book and memory, for one recall trace.
Audits mean a scramble
The week before a notified-body visit, pulling folders and hoping.
The blocks that make the record real.
Electronic device history record
One reviewable record per batch, ready at release instead of hand-collated.
DocumentsLot, serial & UDI traceability
Every component lot tied to its device, forward and back, in seconds.
Data threadE-signed build steps
Scan the lot, sign the step; the record writes itself.
ProductionNCR & CAPA on the floor
Raise it where it happens, quarantine the units, link it to the step.
QualityComponent control & quarantine
Unverified or expired lots hold at goods-in and never reach the bench.
InventoryAudit-ready evidence packs
The ISO 13485 evidence for a batch pulls itself together on demand.
Audits
The eDHR is ready at release.
−79%Time to assemble a device history record at Ravenscroft Medical
97.6%DHR review passed first time
0Re-keys between goods-in and the eDHR
“We build single-use surgical instruments, so every batch needs a complete DHR before it ships. That used to be two days of one QA reviewer collating travellers and lot labels out of lever-arch files. Now the record assembles itself as the operators build, and release is a review, not a rebuild.”
RM
Priya NairQuality Manager at Ravenscroft Medical (ISO 13485 contract manufacturer)
Questions, answered.
01
Is Bulk an eQMS, an MES or an ERP?
None of the three, deliberately. A validated eQMS owns the document side (CAPA, design history, complaint handling); an ERP owns the back office. Bulk runs the build floor between them: lot traceability, e-signed build records, in-process quality and the device history record. Most device makers our size keep their eQMS and accounts platform and use Bulk to replace the paper travellers and spreadsheets in the middle.
02
Can Bulk be my validated quality system for ISO 13485?
No, and we won't pretend otherwise. Bulk is early access and is not a validated eQMS; it will not certify your ISO 13485 QMS. What it does is run the floor so the traceability and in-process evidence behind your certification is captured at source and stays complete. Treat it as the production and traceability layer under your quality system, not a replacement for it.
03
How does the electronic device history record actually get built?
It assembles itself from work already done. As operators build a batch, each e-signed step, scanned component lot and in-process check lands against the unit on one record. At release, the eDHR is that record (component genealogy, UDI, results and sign-offs), reviewed rather than collated from a folder.
04
Does Bulk handle UDI, lot and serial traceability?
Yes, that's the spine. Every component lot is tied to the device and build it went into, forward and back, with UDI and serial captured on the record. A recall or complaint trace becomes a query in seconds instead of cross-referencing a spreadsheet, a label book and memory.
05
Do you support electronic signatures on build steps?
Yes. Build steps are e-signed by the operator as they're completed, with the person, time and step recorded on the device record. We're honest that formal 21 CFR Part 11 / Annex 11 validation is your responsibility as part of your QMS; Bulk gives you the audit trail and signature capture, not a pre-stamped compliance claim.
06
What does it cost, and how long does rollout take?
One per-site price with every module included: traceability, production, quality and documents in the figure, no per-module upsell, hosting and rollout included. Rollout starts with one device family end to end (goods-in to released eDHR, proven on real batches in weeks), then the rest follow on the same pattern. Never a big-bang cutover, and early-access makers work directly with the build team.